Dynesys®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Dynesys® FDA UDI
Generic Name: Spinal dynamic-stabilization system FDA UDI
Model / Reference: 01.03711.100 FDA UDI

Identifiers

Primary DI / UDI-DI: 00889024482241 FDA UDI
FDA Product Code: NQP FDA UDI
GMDN Term: Spinal dynamic-stabilization system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 100 Millimeter FDA UDI

Category: Spinal dynamic-stabilization system

Dynesys is a high-performance, low-profile spinal dynamic-stabilization system designed to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities. Featuring a unique combination of pedicle screws, spacers, and synthetic polymer cords and titanium rods, this system provides adjustable stability for optimal patient outcomes.

Similar devices

Also classified as Spinal dynamic-stabilization system.

DSS Rigid eye connector set, straight, 250mm — Paradigm Spine, LLC · Class II
DSS Rigid eye connector set, straight, 130mm — Paradigm Spine, LLC · Class II
DSS HP Polyaxial pedicle screw set, Ø5 x 50mm — Paradigm Spine, LLC · Class II
DSS Pedicle screw set, Ø8.0 x 50mm — Paradigm Spine, LLC · Class II
DSS Pedicle screw set, Ø8.0 x 60mm — Paradigm Spine, LLC · Class II
DSS HP Polyaxial pedicle screw set, Ø5 x 60mm — Paradigm Spine, LLC · Class II
DSS Pedicle screw set, Ø5.0 x 45mm — Paradigm Spine, LLC · Class II
DSS HP Polyaxial pedicle screw set, Ø8 x 45mm — Paradigm Spine, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Zimmer, Inc.

Sources (1)

FDA UDI c192d957-9319-456f-957c-1f4888724576 34 fields · synced Jun 25, 2026